AtriCure
Design Assurance Quality Engineer
United States of America · Mid · Contract
Sponsorship not specifiedDetected 114 days ago
StatisticsProcess ImprovementGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationMentoring
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- On time quality delivery of assigned product development team deliverables
- Provide subject matter expertise for assigned processes to users as necessary
- Responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions
Responsibilities
- Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations
- Drive continuous improvements through observation, measurement and root cause analysis/resolution
- Develop new processes which support speed, cost reductions and quality improvements
- Provides investigative support/leadership for product quality issues
Requirements
- Experience with quality system process development
- Experience in test method strategies, development and validation including GR&R
- Experience with risk management methodology
- Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
- Ability to demonstrate proficiency in issue resolution.
- Ability to travel 10%
Nice to have
- 3 or more years' experience working with Product Development
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to pass pre-employment drug screen and background check
- AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees.
- For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces.
Skills
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
- Afib affects more than 33 million people worldwide.
- AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.
- AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
- AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients.
- For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Benefits
- https://www.atricure.com/careers-atricure/benefits.
Company info
- We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
- This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development of high-quality products and optimization of core design control business processes.
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This listing is sourced directly from AtriCure's careers page and normalized into a canonical job model.